Surgical implant

ABSTRACT

A surgical implant ( 1 ) in the form of an intervertebral implant defines a cavity ( 2 ) designed to receive bone replacement materials. The bone replacement material is entirely synthetic. With the surgical implant of the present invention, the danger of infection attending a natural bone replacement material is eliminated and, by selecting a synthetic bone replacement material, its physical properties (porosity, pore size, mechanical strength) are no longer exposed to fluctuations.

The present invention relates to a surgical implant defined in the preamble of claim 1, in particular to an intervertebral implant, an intramedullary pin or an intrajoint prosthesis.

Intervertebral implants or other surgical implants comprising cavities designed to be traversed by bones in most instance will be filled during surgery with bones or bony materials in order to allow optimal bone growth through them (the so-called fusion of two vertebras in the case of two vertebras).

The state of the art includes the following procedures:

-   -   (a) filling with autologuous bone chips removed from the         patient's iliac crest; this procedure frequently correlates with         additional patient morbidity,     -   (b) filling the implants with autologuous bone removed from the         adjacent vertebra as regards intervertebral implantations with         anterior access,     -   (c) implant filling using a bony material; this material may be         natural or entirely synthetic; if natural, there is a residual         danger of infection both for an allogenic and a xenogenic         material; moreover the physical properties of a bone-replacement         material may fluctuate substantially when involving the various         donor individuals and body removal sites.

The above state of the art is merely cited as background of the present invention and should not be construed having been actually published or being widely known at the time this application was filed.

The objective of the present invention is palliation. It aims to create an implant which when being implanted already contains an entirely synthetic bone replacement material even in the form of a composite product.

The above problem is solved by the present invention by an implant defined by the features of claim 1.

By resorting to an entirely synthetic bone replacement material, the invention allows averting all above cited drawbacks. As a result it also offers the advantage that—compared to natural bone replacement products—the danger of disease communication is precludes because of the absence of pathogenic proteins, germs, viruses or bacteria.

Preferably the entirely synthetic bone replacement material is made of a calcium phosphate, typically a beta tricalcium phosphate. This feature offers the advantage of using a ceramic of which the stoichiometric composition substantially corresponds to that of the human bone. Furthermore the time of degradation of beta tricalciumphosphate is neither too short nor too long, and consequently cavities or implant residues are averted in the course of degradation.

Also the present invention offers further advantages to the patient. In particular, on account of simplified surgery,

-   -   (a) the time of surgery is substantially shortened,     -   (b) the time under anesthesia is less, and     -   (c) the patient suffers less loss of blood, and, by selecting a         synthetic bone replacement material, the properties of said         material (porosity, pore size, mechanical compressive strength)         are not subjected to fluctuations.

The bone replacement material may be in the form of a rigid element corresponding to the cavity geometry or alternatively in the form of a plastically deforming mass that can be introduced into said cavity.

In a particular embodiment mode, the implant cavity flares conically or cuneately toward the top or the bottom implant surface. As a result the entirely synthetic bone replacement material element inserted into said cavity is press-fitted into the cavity.

However the element also may be affixed by an appropriate fastener, preferably a screw or pin or a stop in the said cavity.

The implant of the invention may comprise a single cavity or several, typically in the latter case from two to eight mutually separate cavities.

Preferably the implant is designed as an intervertebral implant, though it also may be an intramedullary pin or in the form of another osteosynthetic implant or an intrajoint prosthesis.

In one embodiment of the present invention in the form of an intervertebral implant, same is preferably designed as a spacer unit comprising a top and a bottom surface which are appropriate to rest against the end plates of two adjacent vertebras. In this design the cavity does link the spacer unit's top surface to its bottom surface. Appropriately the top surface and/or the bottom surface of said spacer unit are structured in three dimensions, for instance being fluted, grooved, nubbed or in the form of other elevations or indentations.

Preferably the implant shall be transparent to x-rays, in particular consisting of a polymer such as PEEK. The advantage is that fusion may be assessed clinically.

In a further embodiment mode of the present invention, the bone replacement material is resorbing, preferably being hydroxyl apatite or tricalcium phosphate. This feature offers the advantage that because of material resorption, new bone tissue may grow back and need not force itself through the permanent material's pores.

The bone replacement material element advantageously exhibits a porosity of at least 25%, typically at least 35% , at least 50% of the pores exhibiting a diameter preferably in the range of 200 to 500μ.

In a further embodiment mode, the bone replacement material exhibits connections between the individual pores having diameters in the range of 10 to 500μ, preferably 200 to 400μ.

Illustratively the implant may be implemented in that a rigid element corresponding to the cavity geometry and made of an entirely synthetic bone replacement material is pressed into the implant cavity or affixed therein by appropriate fasteners. In another procedure, a moldable and preferably kneadable mass of an entirely synthetic bone replacement material preferably in granular form is introduced into the cavity where it shall be left in the uncured or cured state. This latter procedure also is appropriate for filling the cavities with bone replacement material during surgery.

The invention and its further embodiments are elucidated below in relation to the partly diagrammatic representation of an illustrative embodiment.

FIG. 1 is a perspective of the implant in its unfilled state,

FIGS. 2 is a perspective of the implant in its filled state, and

FIG. 3 is a longitudinal section along line III-III through the implant of FIG. 2.

The implant shown in FIGS. 1 through 3 is an intervertebral implant in the form of a spacer unit comprising four mutually separate cavities 2 that connect the top surface 4 to the bottom surface 5 of the spacer unit. The top surface 4 and the bottom surface 5 are designed to rest against the end plates of two adjacent vertebras and are fitted in part with a 3-dimensional structure 6 in the form of nubs.

As shown by FIG. 3, the cavities 2 flare conically or cuneately or in the form of pyramidical frustra toward the surface 4 of the implant 1 and they contain, as shown in FIG. 2, geometrically corresponding elements 3 made of an entirely synthetic bone replacement material. The elements 3 rest in press-fitted manner in the cavities 2.

The spacer unit is made of PEEK whereas the elements 3 are made of porous hydroxyl apatite. 

1. A surgical implant (1) comprising at least one cavity (2) receiving entirely synthetic bone replacement materials, wherein the cavity (2) flares conically or cuneately toward a top surface of the implant (1).
 2. The implant (1) as claimed in claim 1, wherein said implant comprises 2 to 8 mutually separated cavities (3).
 3. The implant (1) as claimed in claim 1, wherein said implant is formed from an x-ray transparent material.
 4. The implant (1) as claimed in claim 3, wherein the implant is formed from a polymer, and the polymer is PEEK.
 5. The implant (1) as claimed in claim 1, wherein the implant is designed as an intervertebral implant.
 6. The implant (1) as claimed in claim 5, wherein the implant is designed as a support unit comprising the top surface (4) and a bottom surface (5) which are operable to rest against end plates of two adjacent vertebras.
 7. The implant as claimed in claim 6, wherein the top surface (4) and the bottom surface (5) are connected by an element (3).
 8. The implant (1) as claimed in claim 6, wherein at least one of the top surface (4) and the bottom surface (5) comprise a three-dimensional structure (6).
 9. The implant (1) as claimed in claim 1, wherein at least one cavity (2) is filled with an entirely synthetic bone replacement material.
 10. The implant (1) as claimed in claim 9, wherein the bone replacement material (1) is a rigid element (3) corresponding to a geometry of the cavity (2),
 11. The implant (1) as claimed in claim 10, wherein the element (3) rests in press-fitted manner in the cavity (2).
 12. The implant (1) as claimed in claim 10, wherein the element (3) is affixed in the cavity by a fastener.
 13. The implant (1) as claimed in claim 9, wherein the bone replacement material (1) is a plastically deforming mass that can be filled into the cavity (3).
 14. The implant (1) as claimed in claim 10, wherein the element (3) is made of a bone replacement material consisting at least partly of a bio-resorbable material, preferably hydroxyl apatite or tricalcium phosphate.
 15. The implant (1) as claimed in claim 10, wherein the element (3) is made of a bone replacement material having a porosity of between 25% to 35%.
 16. The implant (1) as claimed in claim 10, wherein the element (3) is made of a porous bone replacement material, and wherein at least 50% of the pores of the bone replacement material have a diameter in the range of 200 to 500μ.
 17. The implant (1) as claimed in claim 10, wherein the element (3) is made of a bone replacement material and in that individual pores of the bone replacement material are connected to each other, said pores exhibiting a diameter in the range of 10 to 500μ.
 18. A method to manufacture an implant as claimed in claim 10, comprising the steps of: forming the rigid element (3) from entirely synthetic bone replacement material that corresponds to a geometry of the cavity (2); and, press-fitting the rigid element into the implant cavity (2).
 19. The method to manufacture an implant as claimed in claim 1, comprising the steps of: plastically deforming a mass of entirely synthetic and preferably granular bone replacement material and introducing said bone replacement material into the cavity (2).
 20. The implant as claimed in claim 14, wherein the bio-resorbable material is selected from the group consisting of hydroxyl apatite and tricalcium phosphate 